Food Labeling: Warning and Notice Statement; Labeling of Juice Products; Technical Scientific Workshops; Requests for Additional Time to Achieve the Pathogen Reduction Standard

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 97N-0524]

Food Labeling: Warning and Notice Statement; Labeling of Juice

Products; Technical Scientific Workshops; Requests for Additional Time

to Achieve the Pathogen Reduction Standard

AGENCY: Food and Drug Administration, HHS.

ACTION: Technical scientific workshops; requests for additional time to

achieve the pathogen reduction standard; rule related.

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SUMMARY: The Food and Drug Administration (FDA) is announcing two

technical scientific workshops to discuss and clarify issues related to

the implementation of the agency's rule requiring a warning statement

for certain juice products. In particular, the workshops will address

the pathogen reduction interventions that have been developed for

citrus juice production and the methods for measuring and validating

such systems. FDA is also announcing a process by which individual

manufacturers of citrus juices may request additional time, beyond the

current compliance date of November 5, 1998, to implement a validated

system of control measures that achieves the required reduction in

pathogenic microorganisms. Manufacturers who implement such control

measures will not be required to use the warning statement on their

juice products. These actions are being taken in response to requests

from several fresh citrus juice manufacturers that have indicated they

want to implement improved controls but need additional time to do so.

DATES: The technical scientific workshops will be held on November 12,

1998, and on November 19, 1998. Both workshops will be from 8:30 a.m.

to 5:30 p.m. Registration for the workshops will be provided on a first

come, first served basis and must be received by November 6, 1998.

Individual fresh citrus juice producers may request additional time

to comply with the pathogen reduction standard in Sec. 101.17(g)(7)(i)

(21 CFR 101.17(g)(7)(i)) until December 19, 1998. For requests for

additional time, see the FDA District Directors listed under the

SUPPLEMENTARY INFORMATION section of this document.

ADDRESSES: The technical scientific workshops will be held at the

following locations:

The November 12, 1998, workshop will be held at the Citrus Research

and Education Center, University of Florida, Lake Alfred, FL 33850,

941-956-1151 and

the November 19, 1998, workshop will be held at the FDA District

Office, 19900 MacArthur Blvd., suite 300, Irvine, CA 90015-2486, 949-

252-7592.

For requests for additional time, see the FDA District Directors

listed under the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

To register for a technical workshop, please contact Catherine M.

DeRoever, Center for Food Safety and Applied Nutrition (CFSAN) (HFS-

22), Food and Drug Administration, 200 C St. SW., Washington, DC 20204,

202-205-4251, FAX 202-205-4970 or e-mail ``[email protected]''.

Registration information (including name, title, firm name, address,

telephone and fax numbers) must be received no later than November 6,

1998.

For information on requests for additional time to achieve the

pathogen reduction standard, please contact, as listed in the

SUPPLEMENTARY INFORMATION section of this document, the Director of the

FDA District Office in which the firm is located.

If you need special accommodations due to a disability, please

contact Catherine M. DeRoever at the previous address at least 7 days

in advance.

Interested persons should note that additional information

regarding the technical scientific workshops, making requests for

additional time and other relevant information will be posted on

CFSAN's web site, ``www.cfsan.fda.gov,'' as it becomes available.

Accordingly, such persons may wish to visit that web site on a regular

basis until the workshop convenes.

SUPPLEMENTARY INFORMATION: Requests by individual citrus firms for

additional time to implement control measures and validate that the

process achieves the pathogen reduction in Sec. 101.17(g)(7)(i) should

be addressed to the Director of the FDA District in which the firm is

located. For firms in Florida, Texas, Arizona, and California the

addresses are:

Douglas Tolen, District Director, FDA Florida District Office, 7200

Lake Ellenor Dr., suite 120, Orlando, FL 32809, 407-475-4700;

[[Page 57595]]

Joseph Baca, District Director, FDA Dallas District Office, 3310

Live Oak St., Dallas, TX 75204, 214-655-5315; or

Elaine C. Messa, District Director, FDA Los Angeles District

Office, 19900 MacArthur Blvd., suite 300, Irvine, CA 92612-2445, 949-

798-7714.

In the Federal Register of July 8, 1998 (63 FR 37030), FDA

published a final regulation that requires a warning statement on fruit

and vegetable juice products that have not been processed to prevent,

reduce, or eliminate pathogenic microorganisms that may be present in

such juices. The regulation provides that the warning statement

requirement does not apply to a juice that has been processed in a

manner that will produce, at a minimum, a reduction in the pertinent

microorganism of at least a 5-log magnitude (i.e., 100,000 fold). In

the preamble to the proposed rule (63 FR 20486, April 24, 1998), FDA

recognized that pasteurization is a process that can produce the 5-log

reduction. The agency also noted that manufacturers may be able to use

other technologies and practices, individually or in combination (such

as a combination of eliminating use of drops, brushing, washing and

using sanitizers) to achieve the 5-log reduction, provided that the

manufacturer's process is validated to achieve the 5-log reduction in

the target microorganism.

In the preamble to the final regulation, FDA stated its expectation

that citrus juice processors should be able to achieve and validate a

5-log reduction without pasteurization (63 FR 37030 at 37042). FDA also

indicated that it would be willing to meet with manufacturers or groups

of manufacturers to discuss and evaluate their proposed processes. In

addition, FDA stated that in order to help processors meet the pathogen

reduction standard, the agency would make available, in accordance with

21 CFR part 20 of its regulations, information received by the agency

regarding processes that have been validated to achieve a 5-log

reduction.

FDA has received requests from several manufacturers of fresh

citrus juice for 18-additional months beyond the November 5, 1998,

compliance date for the warning statement requirement to permit such

firms to develop and to validate procedures that will achieve the 5-log

reduction in citrus juices. In discussions with the agency, there was

evidence of widespread confusion among juice manufacturers as to how

FDA expects the 5-log reduction to be achieved.

Upon consideration of the fresh citrus juice manufacturers' request

and in light of other information before the agency regarding progress

made by some citrus juice manufacturers in identifying effective

mechanisms for pathogen reduction, FDA has developed a two-part

strategy to respond to these requests. First, FDA will sponsor two

technical scientific workshops for the citrus juice industry, open to

the public, on November 12 and November 19, l998. Each workshop will

include a discussion of the control measures of which FDA is aware that

are being used for citrus juice production and of the methods for

measuring and validating the effectiveness of the measures in reducing

pathogens. FDA believes that these workshops will provide an

opportunity for industry representatives and other members of the

public to share information regarding control measures that are

believed to achieve the 5-log reduction. Participants are requested to

bring to the workshop at least 150 copies of any written or published

materials they wish to distribute at the workshop. Agency experts will

be available to answer technical questions.

Second, as noted, several firms have requested that FDA extend the

final rule's compliance date for citrus juices to permit those firms

additional time to develop and validate intervention measures that

achieve the 5-log pathogen reduction standard. FDA believes that a

formal extension of the rule's compliance date is not feasible in the

current circumstances because such extension would arguably require

notice and comment rulemaking. Nevertheless, FDA believes that under

certain conditions (which are enumerated as follows), it would be an

appropriate exercise of the agency's enforcement discretion to suspend

enforcement of the final rule for a limited period of time. In

particular, FDA will consider such an exercise of its enforcement

discretion for those citrus juice producers who no later than December

19, 1998, request such consideration and who make the following

commitments in writing:

(1) The firm agrees to use the time period between November 4,

1998, and July 8, 1999, to develop, adapt, and validate procedures that

are sufficient to achieve a 5-log reduction in the pertinent

microorganism; and,

(2) The firm agrees to establish interim protection measures in the

form of a system that applies hazard analysis and critical control

point (HACCP) principles. This interim system will include, at a

minimum, good manufacturing practices and specific control measures

such as chemical washing and brushing of the fruit, sanitizing, culling

of damaged fruit, and utilization of only those types of fruit with

skins that are sufficiently smooth and durable to be cleanable and to

remain intact after cleaning; and,

(3) The firm agrees to comply with the provisions of the warning

label regulation (Sec. 101.17 (g)) no later than July 8, 1999. As a

result of this commitment, the firm will use the warning label on its

products beginning July 8, 1999, if it has been unable to implement

validated control measures that achieve the 5-log reduction.

FDA believes that this two-part strategy is reasonable and will

provide appropriate public health protection. As noted in the warning

statement rulemaking, because the warning statement provides consumers

with important information about the risk of foodborne illness, the

warning requirement contributes to public health protection in that it

allows consumers to make informed purchase decisions. In FDA's view,

this warning statement requirement is primarily an interim step

designed to reduce the risk of fresh juice consumption pending

completion of a final HACCP rule and its implementation. However,

because the warning statement requirement may nevertheless allow

contaminated juice products to reach the marketplace, FDA does not

expect the statement to be as effective in protecting consumers as

would a validated 5-log reduction program. FDA believes it is

appropriate to consider exercising its enforcement discretion where, as

a result of such exercise, the agency can provide an incentive for

citrus juice processing firms to produce safe juice earlier than such

firms would otherwise do.

Because of the relationship between particular provisions in the

warning statement regulation and the HACCP proposal, FDA is announcing

its intention to reopen the comment period on the juice HACCP proposal

(63 FR 20450) entitled ``Hazard Analysis and Critical Control Point

(HACCP); Procedures for the Safe and Sanitary Processing and Importing

of Juice.'' This reopening will allow information and data presented at

the workshop to be included in the record of the HACCP rulemaking. A

Federal Register document announcing the reopening of the juice HACCP

proposal comment period will be published at a later date.

Transcripts of the workshops will be prepared. Copies of the

transcripts may be requested in writing from the Freedom of Information

Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm.

12A-16, Rockville, MD 20857, approximately 15-working

[[Page 57596]]

days after the meetings at a cost of 10 cents per page.

Dated: October 23, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-28901 Filed 10-23-98; 3:47 pm]

BILLING CODE 4160-01-F